GH12-008: Community Home Based India Prevention of Mother To Child Transmission study

摘要 为了解决印度感染艾滋病毒的母亲和儿童的沉重负担，国家艾滋病控制中心 NACO组织(NACO)和马哈拉施特拉邦艾滋病控制协会(MSACS)正准备实施 2010年经修订的世界卫生组织(世卫组织)预防母婴传播艾滋病毒(母婴传播) 指导方针于2012年4月发布。印度最新的防止母婴传播方案有四个主要组成部分：1)提供 向所有感染艾滋病毒的孕妇和哺乳母亲提供抗逆转录病毒治疗；2)促进 纯母乳喂养6个月；3)6周延长奈韦拉平预防用药(Swen) 对所有感染艾滋病毒的婴儿和4)妇女和婴儿在产后艾滋病毒护理中的参与和保留 促进婴儿早期诊断。 我们研究的总体目标是评估提高能力的战略性、综合性和创新性方法 外展工作人员(ORW)在病人家中探望病人，以支持采用预防母婴传播服务。我们的 干预，基于情境信息-动机-行为技能模型的创新适应 关怀启动和维护(SIMB-CIM)被称为基于社区家庭的印度PMTCT(COMBIND 防止母婴传播)研究，并有以下四项战略：1)专门的ORW培训，包括评估 知识保留并提供有针对性的再培训；2)向工作人员提供战略反馈，以改善他们的工作 绩效；3)向母亲提供有针对性的反馈，以加强对4项具体服务的接受；4)使用 开源、屡获殊荣的移动健康(MHealth)平台(EMOCHA)，可促进与 ORW和患者，向提供者、患者和计划提供战略反馈，并优化对 防止母婴传播的4个关键组成部分。中心假设是，提议的干预将导致最优 防止母婴传播4个关键组成部分中的每一个的方案实施。 COMBIND研究的具体目的是：1)检查COMBIND PMTCT对吸收 NACO预防母婴传播计划的四个主要组成部分，采用整群随机试验设计，在四个艾滋病毒高危人群中 马哈拉施特拉邦的负担地区；2)对干预措施进行混合方法评估，以评估影响 拟议的针对妇女和妇女的目标反馈系统的可接受性以及使用和可行性 移动健康平台。我们的研究成功的可能性很高，因为我们的协作、跨学科、 跨机构印美研究小组包括拉克希亚，这是一个非政府组织，其小组 成员在临床和实施科学项目方面有多年的经验；MSACS是 领导马哈拉施特拉邦艾滋病毒/艾滋病项目的卫生部；以及约翰·霍普金斯大学 大学，与印度浦那的Lakshya和BJ医学院有现有的印美合作，并 在临床和实施科学项目的合作研究方面有丰富的经验。

Summary To address the significant burden of HIV-infected mothers and children in India, the National AIDS Control Organization (NACO) and Maharashtra State AIDS Control Society (MSACS) are preparing to implement the 2010 revised World Health Organization (WHO) prevention of mother-to-child HIV transmission (PMTCT) guidelines in April 2012. This updated PMTCT program in India has four major components: 1) Provision of antiretroviral treatment (ART) to all HIV-infected pregnant women and breastfeeding mothers; 2) Promotion of exclusive breastfeeding for 6 months; 3) Administration of six weeks extended nevirapine prophylaxis (SWEN) to all HIV-exposed infants and 4) Engagement and retention of women and infants in postpartum HIV care to facilitate early infant diagnosis. The overall goal of our study is to evaluate a strategic, integrated and innovative approach to improve the capacity of outreach workers (ORWs) visiting patients in their homes, to support uptake of PMTCT services. Our intervention, based on an innovative adaptation of an situated information-motivation-behavioral skills model of care initiation and maintenance (sIMB-CIM), is called COMmunity home Based INDia PMTCT (COMBIND PMTCT) study and has the following four strategies: 1) Specialized ORW training that includes assessments of knowledge retention and provides targeted re-training; 2) Strategic feedback to ORWs, to improve their performance; 3) Targeted feedback to mothers to enhance uptake of the 4 specific services; and 4) Use of an open-source, award-winning mobile health (mHealth) platform (eMOCHA) that facilitates communication with ORWs and patients, provides strategic feedback to the providers, patients and program, and optimizes uptake of the 4 key PMTCT components. The central hypothesis is that intervention proposed will result in optimized program implementation in each of the 4 key PMTCT components. The specific aims of the COMBIND study are: 1) To examine the impact of COMBIND PMTCT on uptake of the four major components of NACO's PMTCT program, using a cluster randomized trial design in four high-HIV burden districts of Maharashtra ; 2) Conduct a mixed-methods evaluation of the intervention to assess the impacts and acceptability of the proposed targeted feedback system for both ORWs and women and use and feasibility of the mHealth platform. Our study has a high likelihood of success because our collaborative, interdisciplinary, inter-institution Indo-US research team include Lakshya, a non-governmental organization (NGO) whose team members have several years of experience in clinical and implementation science projects; MSACS, a division of the Ministry of Health that provides leadership to HIV/AIDS program in Maharashtra State; and Johns Hopkins University, that has existing Indo-US collaboration with Lakshya and BJ Medical College, Pune, India and has extensive experience in collaborative research in clinical and implementation science projects.